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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCORDIS ORION STEERABLE PTCA BALLOON CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameballoon catheter
Regulation Number870.5100
ApplicantCORDIS CORP.
PMA NumberP890032
Supplement NumberS018
Date Received12/20/1993
Decision Date08/04/1995
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for:alternate sterilization site; elimination of chlorofluorocarbons from the sterilization process.
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